Iatrogenic previable premature rupture of membranes (I-PPROM) is defined at breakage of the bag of waters after a prior invasive procedure. This means that leakage of amniotic fluid developed shortly after the procedure. This occurs in less than 1% of patients after genetic amniocentesis, 1-2% of percutaneous needle/shunt procedures, 3-5% after diagnostic fetoscopy, and in approximately 5-8% of patients after operative fetoscopy. Although the membranes (sac in which the baby and amniotic fluid is enclosed) may seal spontaneously in this setting, patients may continue to leak fluid and are at risk for pregnancy loss. The rate of spontaneous resealing varies depending on the cause of the rupture of membranes.
Successful prolongation of pregnancy after I-PPROM is complicated by the fact that the invasive procedure responsible for the complication is typically performed in early pregnancy. Although the natural history of previable PPROM may differ between spontaneous and iatrogenic cases, the overall perinatal mortality of previable PPROM managed expectantly is 60%. Nearly one third of these deaths occur in the womb. Poor lung development (pulmonary hypoplasia) occurs in 50% of cases diagnosed prior to 19 weeks.
Unlike cases of PPROM that occur spontaneously, I-PPROM can be successfully treated with an amniopatch. The amniopatch, which involves intraamniotic injection of platelets and cryoprecipitate, can “seal” the fetal membranes about two-thirds of the time. The rationale for the technique is to allow platelets to gravitate towards the area of injury, and then it is stabilized by the clot formed with cryoprecipitate. This procedure cannot be used in cases of spontaneous PPROM (or if the leaking happened without a prior invasive procedure).
Patient are eligible for the amniopatch if they are between 16-24 weeks with documented I-PPROM within 48 hours of an invasive procedure, who have not undergone a vaginal ultrasound or digital vaginal examination, not in labor or with uterine contractions, and without clinical signs of intraamniotic infection (fever, uterine tenderness, foul smelling amniotic fluid, or fetal tachycardia). Below is a list of the inclusion and exclusion criteria for amniopatch therapy.
- Pregnant women between 16 and 45 years old.
- Patients 16 or more weeks’ gestation who underwent amniocentesis or fetoscopy with documented iatrogenic PROM within 48 hours of procedure who have not undergone a vaginal ultrasound or digital vaginal examination, not in labor or with uterine contractions, and without clinical signs of intraamniotic infection (fever, uterine tenderness, foul smelling amniotic fluid, or fetal tachycardia).
- In labor or with uterine contractions.
- A vaginal ultrasound or digital vaginal examination performed after I-PPROM.
- Signs of intraamniotic infection:
b. Uterine tenderness.
c. Foul smelling amniotic fluid.
d. Fetal tachycardia (fetal heart rate greater than 160 beats per minute).
- Known unbalanced chromosomal complement.
- Previous CVS in this pregnancy.
- Uterine anomalies.
- Large uterine fibroids (>6 cm).
- Dark amniotic fluid suggesting previous bleeding.
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